Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - Revision 1

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Download document Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - Revision 1
Reference number EMA/CVMP/IWP/105506/2007-Rev.1
Status draft: consultation open
First published 2017-09-18
Last updated 2017-09-18
Consultation start date 2017-09-18
Consultation end date 2018-03-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

This guideline was first published in 2010 based on general scientific and regulatory principles in advance of much practical experience from assessing applications through European authorisation procedures. This revision was prepared following a review by CVMP of issues raised by stakeholders based on their experience of operating the guideline. Only minor changes were considered necessary to the guideline itself and an accompanying ‘Question and Answer’ document was produced to address the topics raised by stakeholders that are not specifically addressed within the revised guideline.